NATRELLE Saline-Filled Breast Implants 168-360Recalls & reported problems
Allergan, Inc. · NATRELLE 168-360 Moderate Projection BIOCELL |textured|round|saline · Class 3 · Implant
All models of Natrelle Breast Implants (1167) · NATRELLE Saline-Filled Breast Implants (103)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This NATRELLE Biocell textured saline breast implant is a soft inflatable implant placed inside the breast. Most of the 36 reports describe the implant losing or leaking its saline, or deflating or rupturing, and several describe the scar tissue tightening around the implant (capsular contracture) with pain; some mention visible rippling. No deaths were reported, and all 36 reports describe injuries. One open recall, started in July 2019, concerns the higher incidence of a rare blood-cell cancer (BIA-ALCL) in patients with textured breast implants.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10888628000834), received between Jul 31, 2017 and Aug 26, 2026 — classified as 39 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (31 reports).
1 FDA recall record name this device's identifier, 1 still open.
4 other recalls cover devices cleared under the same FDA submission (P990074); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Jul 24, 2019Class IOpen, Classified
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Z-2451-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak31
- Device Appears to Trigger Rejection7
- Adverse Event Without Identified Device or Use Problem3
- Deflation Problem1
- No Apparent Adverse Event1
Patient problems
- Failure of Implant27
- Capsular Contracture7
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Anxiety1
- Seroma1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2026Device Appears to Trigger Rejection
Patient reported "Capsular Contracture Baker grade IV", "pain" and "exchange from textured to smooth". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50460871 ↗InjuryAug 14, 2026Fluid/Blood Leak
Healthcare professional reported "deflation" and "textured". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50255032 ↗InjuryJul 14, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the right side. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25815955 ↗InjuryMay 19, 2026Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "PAIN", "FLUID" AND "WRINKLE", "TEXTURED TO SMOOTH" AND "FLUID WAS DARK RED" LATER PATIENT REPORTED "I HAVE A HUGE CAPSULE WITH A LARGE AMOUNT OF COMPLEX FLUID AROUND THE IMPLANT INSIDE THE CAPSULE" AND "BREAST IS HIGH UP UNDER MY HARD, HARD AND SWOLLEN". THIS RECORD IS FOR LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 25220086 ↗InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "RIPPLING". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24895487 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "RIPPLING". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24867335 ↗InjuryFeb 20, 2026Fluid/Blood Leak
InjuryFeb 19, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" AND "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24388827 ↗InjuryJan 23, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A "DEFLATION". LATER REPORTED "FEAR ALCL". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24167762 ↗InjuryJan 23, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERNS", "CAPSULAR CONTRACTURE BAKER GRADE IV" AND "PAIN". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24162736 ↗InjuryDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". PATIENT LATER REPORTED "DEFLATION AND REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULE THIN AND NO CAPSULAR CONTRACTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23711306 ↗InjuryNov 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, SUPERIOR DISPLACEMENT OF THE IMPLANTS, WATERFALL DEFORMITY, PAIN AND EXCHANGE FROM TEXTURED TO SMOOTH DEVICES DUE TO THE PATIENTS CONCERN WITH THE PRODUCT". LATER PATIENT'S REPRESENTATIVE REPORTED "SIGNIFICANTLY INCREASED RISK OF DEVELOPING CANCER, LOST WAGES, EMOTIONAL DISTRESS, INCLUDING FEAR AND ANXIETY OF DEVELOPING CANCER, PAST AND FUTURE MEDICAL EXPENSES, PHYSICAL PAIN AND SUFFERING FROM EXPLANTATION, INCLUDING PERMANENT SCARRING AND DISFIGUREMENT". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23574789 ↗InjuryOct 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "PAIN", "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN" AND "REMOVAL OF TEXTURED DEVICES DUE TO PRODUCT CONCERN". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23412052 ↗InjuryNov 12, 2024Fluid/Blood Leak; Fluid/Blood Leak
InjuryAug 22, 2023Device Appears to Trigger Rejection; No Apparent Adverse Event; Device Appears to Trigger Rejection; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL LATER CONFIRMED BAKER GRADE II.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 17595057 ↗InjuryAug 10, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "LEFT SIDE DEFLATION OF TEXTURED IMPLANT." DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17497976 ↗InjuryJul 25, 2023Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "ANY CREASES AND PARTICLES IN VALVE."
Patient problems: Capsular Contracture
MAUDE report 17388526 ↗InjuryJun 28, 2023Fluid/Blood Leak; Fluid/Blood Leak
InjuryMay 17, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION AND EXCHANGE DUE TO PATIENT'S CONCERNS WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16949765 ↗InjuryDec 15, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION AND IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 15992457 ↗InjuryNov 11, 2022Deflation Problem; Fluid/Blood Leak; Deflation Problem; Fluid/Blood Leak
PHYSICIAN REPORTED LEFT SIDE "TEXTURED" AND "RUPTURE". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15781340 ↗InjuryOct 5, 2022Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED LEFT SIDE DEFLATION AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THEIR CONCERN WITH THE PRODUCT. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15546952 ↗InjuryJul 8, 2022Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED "DEFLATION" AND "TEXTURED" AGAINST LEFT DEVICE. HEALTHCARE PROFESSIONAL REPORTED "BILATERAL EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT". THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 14962793 ↗InjuryApr 23, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED " LEFT SIDE DEFLATION." THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14191090 ↗InjuryOct 12, 2021Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "DEFLATION". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 12617089 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P990074. One submission often covers many models, so check the product and lot details in each record.
- Z-0699-2020 · Nov 6, 2019 · TerminatedNatrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI: NATRELLE Style 68LP-125 Saline Round Low 108886280
- Z-0336-06 · Dec 14, 2005 · TerminatedMcGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
- Z-0337-06 · Dec 14, 2005 · TerminatedMcGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360
- Z-0851-05 · May 5, 2005 · TerminatedStyle 363 Saline-Filled BIOCELL textured Breast Implants
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- MENTOR Smooth Round Moderate Profile 3501640Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,294 reports
- MENTOR Smooth Round Moderate Profile 3501680Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,095 reports
- MENTOR Smooth Round Moderate Profile 3501635Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline864 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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